Regulatory framework and approaches to standardization of pharmaceutical care and services

Анотація

The concept of pharmaceutical care transforms the role of pharmacists in the healthcare system, expanding their functions from dispensing medications to counseling and managing pharmacotherapy, especially for chronic diseases. Research shows that integrating pharmacists into multidisciplinary teams improves treatment outcomes for chronic diseases. However, in Ukraine, the practical activities of pharmacists often do not meet the requirements for full implementation of the pharmaceutical care concept. It is necessary to implement not only basic but also specialized pharmaceutical services focused on prevention and medication therapy management. The aim of the work is to analyze the regulatory framework for the provision of pharmaceutical care and pharmaceutical services and approaches to their standardization for further optimization of such services in Ukraine. The research materials included regulatory acts of Ukraine and the EU, documents of pharmaceutical associations, and scientific publications. A systematic approach, content analysis, comparative analysis, and structural-logical method were applied. Definitions of pharmaceutical care and services in various documents were analyzed. The analysis showed that the key EU document is Resolution CM/Res(2020)3, which contains recommendations for implementing pharmaceutical care. In Ukraine, the concepts of pharmaceutical care and services were introduced into the legal field by the new edition of the Law «On Medicines». The main components of care provision were identified: professional interaction, assessment and planning, implementation and optimization, monitoring and evaluation, prevention and education, quality assurance. A hierarchical structure of types of regulatory acts governing standardization was developed. It was established that Ukrainian legislation, having introduced the concepts of pharmaceutical care and services for the first time, corresponds in content to European definitions. The research results emphasize the importance of a comprehensive approach to standardizing pharmaceutical care and services, which considers international experience and national features of the healthcare system. For effective implementation of the pharmaceutical care concept, it is necessary to develop regulatory acts at all levels, including national guidelines, standards, protocols, and standard operating procedures. Particular attention should be paid to developing documents on medication therapy management as a key element of pharmaceutical care, ensuring an individualized approach to treating patients with chronic diseases. Implementation of the proposed hierarchical structure of regulatory documents will allow systematizing the process of providing pharmaceutical care and services, improving their quality and effectiveness. This, in turn, will contribute to optimizing pharmacotherapy, reducing risks associated with medication use, and improving overall public health.

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